Recall Z-2584-2011 ยท DPS Electrocardiograph
Philips Healthcare Inc.
Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureS
| Date | Jun 17, 2011 (initiated Jun 10, 2011) |
| Status | Terminated |
| Reason | Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of audible sound |
| Root cause | Device Design |
| Action | Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken. The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service |
| Quantity | 5225 units |
| Distribution | Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090483 | SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS Philips Medical Systems, Mar 20, 2009 |